The Synchro SELECT Guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Device Description

Like the primary Predicate device, the Synchro SELECT Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature.

The Synchro SELECT Guidewire comes in three stiffness profiles: Soft, Standard, and Support.

AI/ML Overview

The provided text describes the regulatory submission for a medical device (Synchro SELECT Guidewire) and focuses on demonstrating substantial equivalence to a predicate device, rather than providing the kind of detailed performance study data against acceptance criteria that would typically be seen for a novel AI/ML-based device.

Therefore, the information required to answer your specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" for an AI/ML device (e.g., sample size, expert ground truth, MRMC study, standalone performance, training set details) is not present in the provided document.

This document pertains to a physical medical device (guidewire) and its bench testing to establish equivalency to existing devices. The "acceptance criteria" here refer to standard engineering and material performance specifications for a guidewire, not performance metrics of an AI algorithm.

However, I can extract the acceptance criteria and performance data for the physical device based on the provided "Testing Summary" table (Table 2).

Acceptance Criteria and Reported Device Performance (Physical Device)

1. A table of acceptance criteria and the reported device performance

Since this is a physical medical device, the "acceptance criteria" are implied by the test methods and the "Conclusions" represent the reported performance as meeting those criteria.

Test	Acceptance Criteria (Implied by Test Method Summary)	Reported Device Performance (Conclusions)
Coating Lubricity	Hydrophilic coating lubricity assessed after 15 pull cycles through silicone pads.	All Synchro SELECT Guidewires met the specified coating lubricity requirements.
Coating Durability	Coating durability assessed after repeated pull cycles through silicone pads (comparing degradation between Cycle 1-2 and Cycles 31-45).	All Synchro SELECT Guidewires met the specified coating durability requirements.
Torque Response	Evaluate steerability and torque response compared to the predicate device through a tortuous simulated use model.	All Synchro SELECT Guidewires demonstrated acceptable torque response. The torque response of the subject device was comparable to that of the predicate device.
Tip Shape-ability (Visual)	Shape and un-shape the guidewire for a total of five times, then visually inspect the distal tip for any fractures at 40x magnifications.	All Synchro SELECT Guidewires met the specified tip shape-ability requirements.
Tip Shape-ability (Rating)	Shape the tip of the guidewire to 90 degrees and record the tip shaping rating.	All Synchro SELECT Guidewires demonstrated acceptable tip shape-ability. The tip shape-ability of the subject device was comparable to that of the predicate device.
Tip Flexibility	Measure the force required to deflect the guidewire to a specified number of degrees at 20mm.	All Synchro SELECT Guidewires met the specified tip flexibility requirements.
Tensile Strength	Measure the force required to break the guidewire tip.	All Synchro SELECT Guidewires met the specified tensile strength requirements.
Torsional Strength	Record the number of times the proximal end of the wire can be rotated until it exceeds its maximum rotations and fails.	All Synchro SELECT Guidewires met the specified torsional strength requirements.
Flexure	Testing completed per ISO 11070:2014/A1: 2018, Annex G.	All Synchro SELECT Guidewires met the specified flexure requirements.
Fracture	Testing completed per ISO 11070:2014/A1: 2018, Annex F.	All Synchro SELECT Guidewires met the specified fracture requirements.
Tip Integrity (Manipulation)	Shape, straighten, and re-shape the guidewire in the opposite direction for a total of five times. Inspect at 40X for any fractures or breaks.	All Synchro SELECT Guidewires met the specified tip integrity requirements.
Tip Integrity (Simulated Use)	Inspect the guidewire for any damage after tracking through a tortuous simulated use model.	All Synchro SELECT Guidewires demonstrated acceptable tip integrity after being tracked through a tortuous simulated use model.
Particulate Characterization	Count particulates of various size ranges after tracking through a tortuous simulated use model.	Particulate counts were reported and considered acceptable.
Hydrophilic Coating Integrity	Visually inspect and compare hydrophilic coating before and after tracking through a tortuous simulated use model. Additionally, visually inspect device coating after staining the devices.	All Synchro SELECT Guidewires met the specified hydrophilic coating integrity requirements.
Tip-shape Retention	Measure the tip shape retention after tracking the guidewire through a tortuous simulated use model.	All Synchro SELECT Guidewires demonstrated acceptable tip-shape retention. The tip-shape retention of the subject device was comparable to that of the predicate device.
Tip Prolapse	Record the force required for the wire to buckle.	All Synchro SELECT Guidewires met the specified tip prolapse requirements.
Radiopacity	Subject and predicate guidewires evaluated under fluoroscopy.	All Synchro SELECT Guidewires demonstrated acceptable radiopacity. The radiopacity of the subject device was comparable to that of the predicate device.

Regarding the specific questions tailored for AI/ML devices:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The document describes "bench testing" of physical prototypes, not data-driven AI/ML model testing. There is no mention of "data provenance" in the context of patient data for model evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Ground truth, in the AI/ML sense, is not relevant for this physical device testing. The "ground truth" for these tests would be the established engineering specifications and measurement methodologies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided. This concept is for clinical or human reader studies, not bench testing of a guidewire.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states: "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology." Therefore, no MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical guidewire, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable / Not provided. The ground truth for this device is based on engineering specifications, physical measurements, and comparison to predicate devices, as well as adherence to relevant ISO standards.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" as this is not an AI/ML device. The testing described is for physical device verification.

9. How the ground truth for the training set was established

Not applicable / Not provided. Consistent with point 8, there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 25, 2020

Stryker Neurovascular Hailey Hinkle Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538

Re: K202522

Trade/Device Name: Synchro SELECT Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: August 31, 2020 Received: September 1, 2020

Dear Hailey Hinkle:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202522

Device Name Synchro SELECT Guidewire

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification, Special 510(k) Synchro SELECT Guidewire

510(k) Summary

Submitter Name, Address and Content:

Submitter:	Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538-6515(FDA Registration Number: 3008853977)
Contact:	Hailey HinkleStaff Regulatory Affairs SpecialistPhone: 510-413-2500Email: hailey.hinkle@stryker.com
Date Prepared:	August 31, 2020

Device Name and Classification:

Trade/Proprietary Name:	Synchro SELECT™™ Guidewire
Common Name:	Wire, Guide, Catheter
Classification Name:	Wire, Guide, Catheter, 21 CFR 870.1330 – Class I
Product Code:	MOF, DQX

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Legally Marketed Predicate Device

Primary Predicate Device
K053268*	PV 2000 Synchro2Guidewire
Reference Predicate Device
K190843	Synchro2 Support Guidewire
K971254	Transend EX Guidewire

*K053268 was submitted to the FDA by Precision Vascular which was acquired by Boston Scientific which was then acquired by Stryker.

Device Description

The Synchro SELECT Guidewire comes in three stiffness profiles: Soft, Standard, and Support. The primary Predicate, PV 2000 Synchro2 Guidewire (K053268), is only available in the Soft and Standard profiles. Therefore, the reference device, Synchro2 Support (K190843), was included to support the similarity in technical characteristics to the Synchro SELECT Support stiffness profile. Certain design inputs and associated acceptance criteria for PV 2000 Synchro2 (K053268) and Synchro2 Support (K190843) were based on the reference device, Transend EX (K971254).

Accessories

The Synchro SELECT Guidewire is shipped with a Torque Device that is commercially available from Merit Medical (K936032), and a Guidewire Introducer that is commercially available from B. Braun (K760389).

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Indications for Use

The Indications for Use for the Synchro SELECT Guidewire are the same as the primary Predicate PV 2000 Synchro2 Guidewire and the reference Predicate Synchro2 Support Guidewire and are as follows:

The Synchro SELECT Guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.

Technological Characteristics and Product Feature Comparison

The Synchro SELECT Guidewire is substantially equivalent to the Predicate device, the PV 2000 Synchro2 Guidewire, cleared under K053268, based on the following:

Same indications for use .
Same fundamental materials and manufacturing process ●
Same fundamental design and technology
Same operating principles
Same biocompatibility information
Same materials and processes for packaging
. Same sterilization method and process for devices

A comparison of the Subject device with the Predicate device is summarized in Table 1 below.

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	Predicate Device PV 2000Synchro2 Guidewire (K053268)	Subject DeviceSynchro SELECT Guidewire
Classification Name:	Wire, Guide, Catheter, 21 CFR870.1330 - Class II	Same
Product Code	DQX	MOF, DQX
Review Panel	Neurology	Same
510(k) Submitter1:	Stryker Neurovascular47900 Bayside PkwyFremont, CA94538-6515	Same
Indications for Use	The PV 2000 Synchro2Guidewire series of products areintended for general intravascularuse, including the neuro andperipheral vasculature. Thedevice can be used to selectivelyintroduce and position cathetersand other interventional deviceswithin the peripheral andneurovasculature. This deviceshould be used only byphysicians trained inpercutaneous, intravasculartechniques and procedures.	Same
	Predicate Device PV 2000Synchro2 Guidewire (K053268)	Subject DeviceSynchro SELECT Guidewire
DeviceDescription/Principleof Operation	The PV 2000 Synchro2 Guidewireseries is a single-use product with ashapeable tip, used to gainintravascular access to and facilitatethe positioning and exchange ofinterventional devices in smalldiameter, tortuous vasculature forneuro and peripheral diagnostic andinterventional procedures. Thewire can be torqued to facilitatenavigation through the vasculature.	Same
Target Population	The PV 2000 Synchro2Guidewire series will be used inpatients undergoing endovasculartreatment includingneurovascular and peripheralvasculatures.	Same
Accessories	Guidewire Introducer, TorqueDevice	Same
Core Wire	304 Stainless Steel, PTFE Coatedon the proximal section	Same
Core Wire Length	200cm Access Length300cm Exchange Length	215cm Access Length300cm Exchange Length
Guidewire Tip	Nickel-Titanium,Micro-Machined Nitinol	Same
Radiopaque Coil	Platinum, 10cm	Standard and Soft: Platinum,10cmPre-shaped Support: Platinum,7cmStraight Support: Platinum, 6cm
	Predicate Device PV 2000Synchro² Guidewire (K053268)	Subject DeviceSynchro SELECT Guidewire
Adhesive	UV Curable Adhesive	Same
Primer	Parylene Dimer	Same
Hydrophilic TopCoat	Proprietary Hydrophilic TopCoat	Same
Hydrophilic BaseCoat	Proprietary Hydrophilic BaseCoat	Same
GuidewireIntroducer	Commercially available perK760389	Same
Torque Device	Commercially available perK936032	Same
Dispenser Hoop	High Density Polyethylene	Same
Accessory Card	Clay Coated Solid BleachedSulfate (CCSBS)	Same
Sterile Pouch	Tyvek® - Polyethylene	Same
Shipping Carton	Solid Bleached Sulphate (SBS)	Same
Sterilization Method	100% Ethylene Oxide	Same
How Supplied	Single Use/Sterile	Same

Table 1. Product Feature Comparison of Subject Device to Predicate Device

1 K053268 was submitted to the FDA by Precision Vascular which was acquired by Boston Scientific which was then acquired by Stryker.

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Premarket Notification, Special 510(k)
Synchro SELECT Guidewire

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Premarket Notification, Special 510(k) Synchro SELECT Guidewire

The differences between the devices do not raise new questions of safety and effectiveness.

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Risk Assessment

Risk assessment of the Synchro SELECT Guidewire has been conducted in accordance with ISO 14971:2007. The risk documentation was updated to support the modifications, and Stryker Neurovascular has determined that the modifications to the primary Predicate device raise no new questions of safety or effectiveness. The modifications did not result in any new failure modes nor were there any changes to existing failure modes. Results of confirmatory testing have demonstrated the Subject device is substantially equivalent to the primary Predicate device.

Testing Summary

Well-established test methods were used to evaluate the Subject device. All design inputs and associated acceptance criteria are identical to that of the primary Predicate (PV 2000 Synchro2 Guidewire, K053268) and the reference device (Synchro2 Support Guidewire, K190843). Some of the design inputs and associated acceptance criteria for PV 2000 Synchro? (K053268) and Synchro2 Support (K190843) were based on the reference device, Transend EX (K971254). The results of confirmatory testing conducted on the Subject device demonstrate that it performs as designed and is suitable for its intended use. A summary of the tests performed on the Subject device is provided below in Table 2.

Test	Test Method Summary	Conclusions
Coating Lubricity	Hydrophilic coating lubricitywas assessed after 15 pullcycles through silicone pads.	All Synchro SELECTGuidewires met the specifiedcoating lubricity requirements.
Coating Durability	Coating durability wasassessed after repeated pullcycles through silicone pads(comparing degradation betweenCycle 1-2 and Cycles 31-45).	All Synchro SELECTGuidewires met the specifiedcoating durabilityrequirements.
Test	Test Method Summary	Conclusions
Torque Response	Track the guidewire through atortuous simulated use modeland evaluate the steerabilityand torque response comparedto the predicate.	All Synchro SELECTGuidewires demonstratedacceptable torque response.The torque response of thesubject device was comparableto that of the predicate device.
Tip Shape-ability	Shape and un-shape theguidewire for a total of fivetimes then visually inspect thedistal tip for any fractures at40x magnifications.	All Synchro SELECTGuidewires met the specifiedtip shape-ability requirements.
Tip Shape-ability	Shape the tip of the guidewireto 90 degrees and record thetip shaping rating.	All Synchro SELECTGuidewires demonstratedacceptable tip shape-ability.The tip shape-ability of thesubject device was comparableto that of the predicate device.
Tip Flexibility	Measure the force required todeflect the guidewire to aspecified number of degrees at20mm.	All Synchro SELECTGuidewires met the specifiedtip flexibility requirements.
Tensile Strength	Measure the force required tobreak the guidewire tip.	All Synchro SELECTGuidewires met the specifiedtensile strength requirements.
Torsional Strength	Record the number of timesthe proximal end of the wirecan be rotated until it exceedsits maximum rotations andfails.	All Synchro SELECTGuidewires met the specifiedtorsional strengthrequirements.
Flexure	Testing completed per ISO11070:2014/A1: 2018, AnnexG	All Synchro SELECTGuidewires met the specifiedflexure requirements.
Test	Test Method Summary	Conclusions
Fracture	Testing completed per ISO11070:2014/A1: 2018, AnnexF	All Synchro SELECTGuidewires met the specifiedfracture requirements.
Tip Integrity	Shape, straighten, and re-shapethe guidewire in the oppositedirection for a total of fivetimes. Inspect at 40X for anyfractures or breaks.	All Synchro SELECTGuidewires met the specifiedtip integrity requirements.
	Inspect the guidewire for anydamage after tracking througha tortuous simulated usemodel.	All Synchro SELECTGuidewires demonstratedacceptable tip integrity afterbeing tracked through atortuous simulated use model.
Particulate Characterization	Count particulates of varioussize ranges after trackingthrough a tortuous simulateduse model.	Particulate counts werereported and consideredacceptable.
Hydrophilic Coating Integrity	Visually inspect and comparehydrophilic coating before andafter tracking through atortuous simulated use model.Additionally, visually inspectdevice coating after stainingthe devices.	All Synchro SELECTGuidewires met the specifiedhydrophilic coating integrityrequirements.
Tip-shape Retention	Measure the tip shaperetention after tracking theguidewire through a tortuoussimulated use model.	All Synchro SELECTGuidewires demonstratedacceptable tip-shape retention.The tip-shape retention of thesubject device was comparableto that of the predicate device.
Test	Test Method Summary	Conclusions
Tip Prolapse	Record the force required forthe wire to buckle.	All Synchro SELECTGuidewires met the specifiedtip prolapse requirements.
Radiopacity	Subject and predicateguidewires evaluated underfluoroscopy.	All Synchro SELECTGuidewires demonstratedacceptable radiopacity. Theradiopacity of the subjectdevice was comparable to thatof the predicate device.

Table 2. Confirmation Testing Summary

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Premarket Notification, Special 510(k)
Synchro SELECT Guidewire

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Premarket Notification, Special 510(k)
Synchro SELECT Guidewire

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Premarket Notification, Special 510(k) Synchro SELECT Guidewire

Performance Data - Animal, Clinical

No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology. Substantial equivalence of the Subject device has been established to the Predicate devices through the results of bench testing.

Sterilization and Shelf Life Testing

The device and its accessories are sterilized by 100% Ethylene Oxide and have been adopted into a validated sterilization process in accordance with the principles of ISO 11135:2014 ("Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices"). This statement is supported by a standards assessment conducted by Stryker. A sterility assurance level (SAL) of 10-6 has been demonstrated.

There are no fundamental material changes compared to the predicate device. All components that are changing are metal, which are not affected by aging. There are no changes to existing shelf life. As with the Predicate device, the Synchro SELECT Guidewire is labeled with a 3-year shelf life.

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Stryker Neurovascular Premarket Notification, Special 510(k) Synchro SELECT Guidewire

Biocompatibility

Biocompatibility testing was conducted for the Predicate device (K053268). These results apply to the Subject device because it uses the same materials and processes as previously cleared primary Predicate device. The results demonstrate that the Subject device with its accessories meet biological safety requirements per ISO 10993-1:2009 ("Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ") for externally communicating medical devices with circulating blood contact for less than 24 hours. This statement is supported by standards assessment conducted by Stryker.

Conclusion

The Subject device is substantially equivalent to the Predicate device with regards to device design, materials, intended use, and patient population. The conclusions drawn from the risk assessments and confirmatory testing conducted demonstrate that the Subject device performs as designed, is as safe, as effective, and performs as well as the Predicate device.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.